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FDA 510(k)

Disposable Injection Needles

K-Number: K232200 · 2024-04-12

ApplicantNingbo Xinwell Medical Technology Co., Ltd.
Decision Date2024-04-12
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Injection Needles is a medical device manufactured by Ningbo Xinwell Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-12 under approval number K232200. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Injection Needles?

Disposable Injection Needles is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Ningbo Xinwell Medical Technology Co., Ltd.. The 510(k) number is K232200.

When was Disposable Injection Needles approved by the FDA?

Disposable Injection Needles received FDA 510(k) clearance on 2024-04-12, under approval number K232200.

What company makes Disposable Injection Needles?

Disposable Injection Needles is manufactured by Ningbo Xinwell Medical Technology Co., Ltd..

What is the FDA product code for Disposable Injection Needles?

The FDA product code for Disposable Injection Needles is FBK.

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Other Devices by Ningbo Xinwell Medical Technology Co., Ltd.

K232969Disposable Hemostatic Clips

Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K151475EndoChoice Select Injection NeedleEndochoice, Inc. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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